INDICATIONS
For the relief of symptoms of depression. Endogenous depression
is more likely to be alleviated than are other depressive
states.
DOSAGE AND ADMINISTRATION
Oral Dosage
Dosage should be initiated at a low level and increased
gradually, noting carefully the clinical response and
any evidence of intolerance.
Initial Dosage for Adults:
For outpatients 75 mg of amitriptyline HCl a day in divided
doses is usually satisfactory. If necessary, this may
be increased to a total of 150 mg per day. Increases are
made preferably in the late afternoon and/or bedtime doses.
A sedative effect may be apparent before the antidepressant
effect is noted, but an adequate therapeutic effect may
take as long as 30 days to develop.
An alternate method of initiating therapy in outpatients
is to begin with 50 to 100 mg amitriptyline HCl at bedtime.
This may be increased by 25 or 50 mg as necessary in the
bedtime dose to a total of 150 mg per day.
Hospitalized patients may require 100 mg a day initially.
This can be increased gradually to 200 mg a day if necessary.
A small number of hospitalized patients may need as much
as 300 mg a day.
Adolescent and Elderly Patients: In general, lower dosages
are recommended for these patients. Ten mg 3 times a day
with 20 mg at bedtime may be satisfactory in adolescent
and elderly patients who do not tolerate higher dosages.
Maintenance: The usual maintenance
dosage of amitriptyline HCl is 50 to 100 mg per day. In
some patients 40 mg per day is sufficient. For maintenance
therapy the total daily dosage may be given in a single
dose preferably at bedtime. When satisfactory improvement
has been reached, dosage should be reduced to the lowest
amount that will maintain relief of symptoms. It is appropriate
to continue maintenance therapy 3 months or longer to
lessen the possibility of relapse.
Intramuscular Dosage
Initially, 20 to 30 mg (2 to 3 ml) four times a day.
When amitriptyline HCl injection is administered intramuscularly,
the effects may appear more rapidly than with oral administration.
When amitriptyline HCl injection is used for initial
therapy in patients unable or unwilling to take amitriptyline
HCl tablets, the tablets should replace the injection
as soon as possible.
Usage in Pediatric Patients:
In view of the lack of experience with the use of this
drug in children, it is not recommended at the present
time for patients under 12 years of age.
Plasma Levels: Because of the
wide variation in the absorption and distribution of tricyclic
antidepressants in body fluids, it is difficult to directly
correlate plasma levels and therapeutic effect. However,
determination of plasma levels may be useful in identifying
patients who appear to have toxic effects and may have
excessively high levels, or those in whom lack of absorption
or noncompliance is suspected. Adjustments in dosage should
be made according to the patient's clinical response and
not on the basis of plasma levels.14
HOW SUPPLIED
Tablets:
Elavil, 10 mg, are blue, round, film
coated tablets, identified with "40" debossed
on one side and "Elavil" on the other side.
Elavil, 25 mg, are yellow, round, film
coated tablets, identified with "45" debossed
on one side and "Elavil" on the other side.
Elavil, 50 mg, are beige, round, film
coated tablets, identified with "41" debossed
on one side and "Elavil" on the other side.
Elavil, 75 mg, are orange, round, film
coated tablets, identified with "42" debossed
on one side and "Elavil" on the other side.
Elavil, 100 mg, are mauve, round, film
coated tablets, identified with "43" debossed
on one side and "Elavil" on the other side.
Elavil, 150 mg, are blue, capsule shaped,
film coated tablets, identified with "47" debossed
on one side and "Elavil" on the other side.
Injection:
Elavil, 10 mg/ml, is a clear, colorless
solution, and is supplied in 10 ml vials:
Storage: Store amitriptyline HCl tablets
in a well-closed container. Avoid storage at temperatures
above 30°C (86°F). In addition, amitriptyline
HCl tablets 10 mg must be protected from light and stored
in a well-closed, light-resistant container.
Protect amitriptyline HCl injection from freezing and
avoid storage above 30°C (86°F).
REFERENCES
1. Ayd FJ Jr: Amitriptyline therapy for depressive reactions.
Psychosomatics 1960;1:320-325.
2. Diamond S: Human metabolizer of amitriptyline tagged
with carbon 14. Curr Ther Res, Mar 1965, pp 170-175.
3. Dorfman W: Clinical experiences with amitriptyline:
A preliminary report. Psychosomatics 1960;1:153-155.
4. Fallette JM, Stasney CR, Mintz AA: Amitriptyline poisoning
treated with physostigmine. South Med J 1970;63:1492-1493.
5. Hollister LE, Overall JE, Johnson M, et al: Controlled
comparison of amitriptyline, imipramine and placebo in
hospitalized depressed patients. J Nerv Ment Dis 1964;139:370-375.
6. Hordern A, Burt CG, Holt NF: Depressive states: A pharmacotherapeutic
study, Springfield study. Springfield, III, Charles C.
Thomas, 1965.
7. Jenike MA: Treatment of Affective Illness in the Elderly
with Drugs and Electroconvulsive Therapy. J Geriatr Psychiatry
1989;22(1):77-112.
8. Klerman GL, Cole JO: Clinical pharmacology of imipramine
and related antidepressant compounds. Int J Psychiatry
1976;3:267-304.
9. Liu B, Anderson G, Mittman N, et al: Use of selective
serotonin-reuptake inhibitors or tricyclic antidepressants
and risk of hip fractures in elderly people. Lancet 1998;351(9112):1303-1307.
10. McConaghy N, Joffe AD, Kingston WR, et al: Correlation
of clinical features of depressed outpatients with response
to amitriptyline and protriptyline. Br J Psychiatry 1968;114:103-106.
11. McDonald IM, Perkins M, Marjerrison G, et al: A controlled
comparison of amitriptyline and electroconvulsive therapy
in the treatment of depression. Am J Psychiatry 1966;122:1427-1431.
12. Slovis T, Ott J, Teitelbaum, et al: Physostigmine
therapy in acute tricyclic antidepressant poisoning. Clin
Toxicol 1971;4:451-459.
13. Symposium on depression with special studies of a
new antidepressant, amitriptyline. Dis Nerv Syst, (Sect
2) May 1961, pp 5-56.
14. Hollister LE: JAMA 1979;241:2350-2533.
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